Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate
- Conditions
- Testosterone Deficiency
- Interventions
- Registration Number
- NCT05096169
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl).
- Detailed Description
This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl). The investigators will perform a pharmacokinetic analysis of serum hormone concentrations (TT, LH, FSH, estradiol) after medication administration. Researchers hypothesize that testosterone levels will increase in both groups and this may allow to dose clomiphene citrate so that patients do not need to take the medication daily.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- 40
- Male, 21-45 years of age
- Serum testosterone concentration < 300 ng/dl measured on two separate occasions (separated by at least one week), with collection prior to 10AM
- Serum testosterone concentration > 300 ng/dl
- Abnormal serum prolactin (PRL) concentration (PRL > 15.2 ng/ml)
- Concurrent or prior use of hormone-modifying medications (clomiphene citrate or other SERM, testosterone replacement therapy or other testosterone-containing products/treatments, gonadotropin therapy, aromatase inhibitors, estrogen-containing products/treatments)
- Documented karyotype abnormality
- Diagnosis of Kallmann syndrome
- Any prior chemotherapy, radiation therapy to the groin/pelvis, or known exposure to gonadotoxic agents
- History of cryptorchidism or prior orchiopexy
- History of testicular cancer or prior orchiectomy
- History of pituitary tumor or resection of pituitary tumor
- History of prostate cancer or severe benign prostatic hypertrophy
- History of epididymitis or epididymo-orchitis, or orchitis (including mumps)
- History of primary hypogonadism
- History of prior urinary tract infection
- History of intravenous drug use
- Any of the following comorbidities: renal insufficiency, heart disease, peptic ulcer disease, cerebrovascular disease, liver disease, psychiatric disorders, chronic pain, bleeding diatheses, anemia, polycythemia, vision problems
- Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
- Documented allergy or hypersensitivity to clomiphene citrate or other SERM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clomiphene citrate 25 mg daily for 12 weeks Clomiphene Citrate 25mg - Clomiphene citrate 50 mg every other day for 12 weeks Clomiphene Citrate 50mg -
- Primary Outcome Measures
Name Time Method Change in serum testosterone Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. Change in serum testosterone
- Secondary Outcome Measures
Name Time Method Change in FSH levels Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. Serum levels of follicle-stimulating hormone (FSH)
Change in LH levels Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. Serum levels of luteinizing hormone (LH)
Change in estradiol levels Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. Serum levels of estradiol levels
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States